DEXMEDETOMIDINE for Thoracoscopic lung resection surgery

Inclusion criteria

• {"criterion_text":"- Adult patients aged 60 years or older"}
• {"criterion_text":"- Patients scheduled for thoracoscopic lung resection surgery"}

Exclusion criteria

• {"criterion_text":"- Lack of informed consent or inability to give informed consent"}
• {"criterion_text":"- 2nd- or higher degree atrioventricular block without pacemaker"}
• {"criterion_text":"- urgent, not elective surgery"}

Primary endpoints

• {"endpoint_text":"- (Early) quality of recovery on day 1 following surgery compared to preoperative value, assessed by the quality of recovery score (QoR-15).","definition_or_measurement_approach":"Assessed by the quality of recovery score (QoR-15) comparing day 1 post-surgery to preoperative value."}

Secondary endpoints

• {"endpoint_text":"- The Quality of Recovery Score (QoR-15) will be used to assess the early postoperative health status of the patient, i.e. the quality of recovery","definition_or_measurement_approach":"Measured using the QoR-15 questionnaire to assess early postoperative health status/quality of recovery."}
• {"endpoint_text":"- Postoperative muscle strength (lower extremity) and physical ability, assessed by the Timed Up and Go test (TUG)","definition_or_measurement_approach":"Measured by the Timed Up and Go test (TUG) to assess lower extremity strength and physical ability."}
• {"endpoint_text":"- Postoperative muscle function and decrease in strength (upper extremity) postoperatively will be assessed by comparing the handgrip strength of the dominant hand, measured by the CAMRY dynamometer","definition_or_measurement_approach":"Measured by handgrip strength of the dominant hand using a CAMRY dynamometer; comparison pre/postoperative."}
• {"endpoint_text":"- To assess general fatigue a fatigue questionnaire, the Chalder fatigue questionnaire, will be taken","definition_or_measurement_approach":"Measured using the Chalder fatigue questionnaire."}
• {"endpoint_text":"- To assess fatigue more in detail the fatigue VAS scale will be taken","definition_or_measurement_approach":"Measured using a fatigue visual analogue scale (VAS)."}
• {"endpoint_text":"- The EQ-5D questionnaire will be taken to assess health-related quality of life","definition_or_measurement_approach":"Measured using the EQ-5D questionnaire to assess health-related quality of life."}
• {"endpoint_text":"- Electroencephalographic (EEG) readings will be conducted (in a subcohort of patients) during the first postoperative night (when administering study medication) via a compact/wearable medical device for recording brain activity","definition_or_measurement_approach":"EEG recordings via a compact/wearable device during the first postoperative night in a subcohort."}
• {"endpoint_text":"- To evaluate each patient’s sleep-wake cycle, the sleep-wake timing will be evaluated with the Munich ChronoType Questionnaire (MCTQ), which will be used to calculate the baseline midpoint sleep and chronotype","definition_or_measurement_approach":"Assessed via the Munich ChronoType Questionnaire (MCTQ) to calculate baseline midpoint sleep and chronotype."}
• {"endpoint_text":"- To assess subjective sleep quality the Pittsburgh Sleep Quality Index (PSQI; a seven-item questionnaire consisting of 19 self-rated questions that assess sleep quality over the last month, each weighted equally on a 0-3 scale; higher scores indicate worse sleep quality) will be used","definition_or_measurement_approach":"Measured using the Pittsburgh Sleep Quality Index (PSQI) questionnaire (19 self-rated questions)."}
• {"endpoint_text":"- The evolution of sleep pre- and postoperatively will be evaluated with the Consensus Sleep Diary to have a more depth insight into the evolution of sleep pre- and postoperatively","definition_or_measurement_approach":"Assessed using the Consensus Sleep Diary to evaluate pre- and postoperative sleep evolution."}
• {"endpoint_text":"- The Richards-Campbell Sleep Questionnaire (RCSQ) will be taken to evaluate the subjective quality of the first night after surgery","definition_or_measurement_approach":"Measured using the Richards-Campbell Sleep Questionnaire (RCSQ) for subjective quality of the first postoperative night."}
• {"endpoint_text":"- To assess postoperative delirium the 3 minute confusion assessment method (3D-CAM) questionnaire will be done","definition_or_measurement_approach":"Assessed using the 3D-CAM (3 minute confusion assessment method) questionnaire."}
• {"endpoint_text":"- To assess postoperative cognitive impairment the Telephone Interview for Cognitive Status (TICS-40) will be done","definition_or_measurement_approach":"Assessed using the TICS-40 (Telephone Interview for Cognitive Status) to evaluate cognitive impairment."}
• {"endpoint_text":"- NRS pain scores 0-10","definition_or_measurement_approach":"Measured using Numerical Rating Scale (NRS) for pain from 0 to 10."}
• {"endpoint_text":"- The occurrence of PONV","definition_or_measurement_approach":"Recorded occurrence of postoperative nausea and vomiting (PONV)."}
• {"endpoint_text":"- Markers of the inflammatory surgical response will be determined","definition_or_measurement_approach":"Measured by laboratory assessment of markers of inflammatory surgical response (details not specified)."}
• {"endpoint_text":"- Melatonin production will be monitored","definition_or_measurement_approach":"Melatonin production monitoring (method not specified)."}

Belgium

Earliest CTIS Part Ii Submission Date

04-03-2024

Latest Decision Or Authorization Date

02-04-2024

Processing Time Days

29

Number Of Sites

1

Number Of Participants

102

Primary sponsor

Full Name

Ziekenhuis Oost Limburg

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium